NCT04284397 Identification of Critical Thermal Environments for Aged Adults
| NCT ID | NCT04284397 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Penn State University |
| Condition | Aging |
| Study Type | INTERVENTIONAL |
| Enrollment | 190 participants |
| Start Date | 2020-12-30 |
| Primary Completion | 2027-02-27 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 190 participants in total. It began in 2020-12-30 with a primary completion date of 2027-02-27.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study evaluates critical environmental limits (temperature and humidity) above which older adults are unable to effectively thermoregulate. Participants will exercise in a series of different environmental conditions to identify combinations of temperature and humidity above which age-related physiological changes cause uncompensable heat stress, resulting in increased risk of heat illness.
Eligibility Criteria
Inclusion Criteria: * Adults aged 18 and older (those 40+ years of age must be cleared by collaborating physician) * All premenopausal women will be eumenorrheic (by survey) * Asymptomatic and no signs/symptoms of disease according to the American College of Sports Medicine 10th edition Guidelines for Exercise Testing and Prescription Exclusion Criteria: * Medications that affect thermoregulatory or cardiovascular responses to exercise * Any contraindications to low intensity physical activity on the Physical Activity Readiness Questionnaire * Any mobility restrictions that interfere with low intensity physical activity * Pregnant or planning to become pregnant in the next 12 months * Prior diagnosis of cancer, cardiovascular disease, diabetes, or metabolic syndrome * Illegal/recreational drug use * History of Chron's disease, diverticulitis, or similar gastrointestinal disease * Abnormal resting or exercise electrocardiogram (ECG)
Contact & Investigator
W. Larry Kenney, Ph.D.
PRINCIPAL INVESTIGATOR
The Pennsylvania State University
Frequently Asked Questions
Who can join the NCT04284397 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Aging. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04284397 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04284397 currently recruiting?
Yes, NCT04284397 is actively recruiting participants. Contact the research team at lma191@psu.edu for enrollment information.
Where is the NCT04284397 trial being conducted?
This trial is being conducted at University Park, United States.
Who is sponsoring the NCT04284397 clinical trial?
NCT04284397 is sponsored by Penn State University. The principal investigator is W. Larry Kenney, Ph.D. at The Pennsylvania State University. The trial plans to enroll 190 participants.